System and a method for delivery of an annuloplasty implant

ABSTRACT

A delivery system and method for delivery of an annuloplasty implant for a patient are disclosed. The delivery system comprises a commissure locator device for locating a commissure, comprising; an extension member, a catheter, and wherein the extension member is extendable relative the catheter for location of at least one commissure of a cardiac valve, and a coronary sinus contractor for temporary insertion into the coronary sinus (CS) and having a displacement unit being temporarily transferable to an activated state in Which the shape of the annulus Of the heart valve is modified to a modified shape to be retained by said annuloplasty implant.

RELATED APPLICATIONS

This application is a continuation of and claims priority to U.S. patentapplication Ser. No. 15/119,702 filed Aug. 17, 2016 entitled A SystemAnd A Method For Delivery Of An Annuloplasty Implant, which is the U.S.National Phase of International Patent Application No.PCT/EP2015/053421, International Filing Date Feb. 18, 2015 entitled ASystem And A Method For Delivery Of An Annuloplasty Implant, whichclaims benefit of and priority to U.S. Provisional Application Ser. No.61/940,857 filed Feb. 18, 2014 entitled Steering System For DeploymentAnd/Or Retrieval Of Interventional Heart Devices; European PatentApplication No. 14155506.0 filed Feb. 18, 2014 entitled Stapling Device;European Patent Application No. 14155508.6 filed Feb. 18, 2014 entitledMedical Device For A Cardiac Valve Implant; and European PatentApplication No. 14179416.4 filed Jul. 31, 2014, all of which are herebyincorporated herein by reference in their entireties.

BACKGROUND OF THE INVENTION Field of the Invention

This disclosure pertains in general to the field of medical devices.More particularly the disclosure relates to a system for delivery of anannuloplasty implant.

Description of the Prior Art

It is known today that an annuloplasty implant for reshaping cardiacvalves is of great importance to ensure greatest possible effect in therepair of the cardiac valve(s). A variety of tools to deploy theannuloplasty implant is known and they involve the use of a puncturedevice to gain entrance to the heart chamber and then a tool to fordeploying the annuloplasty implant.

A problem with today's known technology is that the deploying of theannuloplasty implant is difficult and thus requires a long time whichendangers the health of the patient.

A further problem of today's systems is the difficulty for the operatorto quickly and with ease deploy the annuloplasty implant at its desiredlocation without the need to use a trial and error approach. Furtherproblems with today's systems include difficulties in positioningannuloplasty implants in a more accurate way.

Thus, there is a need for an improved system and method for deliveringan annuloplasty implant.

SUMMARY OF THE INVENTION

Accordingly, examples of the present disclosure preferably seek tomitigate, alleviate or eliminate one or more deficiencies, disadvantagesor issues in the art, such as the above-identified, singly or in anycombination by providing a medical device and a method for use thereofthat facilitates a selection of a size and/or shape of an annuloplastyimplant, according to the appended patent claims.

According to aspects of the invention, a system and method for deliveryof an annuloplasty implant are disclosed.

According to a first aspect of the invention, a delivery system isprovided, the delivery system for delivering an annuloplasty systemcomprises a commissure locator device for locating a commissure,comprising an extension member, a catheter, and wherein the extensionmember is extendable relative the catheter for location of at least onecommissure of a cardiac valve, and a coronary sinus contractor fortemporary insertion into the coronary sinus (CS) and having adisplacement unit being temporarily transferable to an activated statein which the shape of the annulus of the heart valve is modified to amodified shape to be retained by said annuloplasty implant.

According to a second aspect of the invention, a method of implanting anannuloplasty implant is provided comprising locating and substantiallyfixating the position the commissures of the heart valve by positioninga commissure locator device at the commissures, inserting a flexible andremovable elongate displacement unit in a delivery state into a coronarysinus (CS) adjacent the valve, activating the displacement unit in anactivated state whereby the shape of the annulus is modified to amodified shape, inserting said implant around the annulus of the heartvalve, fixating said implant at the mitral valve annulus when themodified shape is obtained, removing the elongate displacement unitafter temporary activation in the activated state.

Further examples of the disclosure are defined in the dependent claims,wherein features for the second and subsequent aspects of the disclosureare as for the first aspect mutatis mutandis.

Some examples of the disclosure provide for a delivery system havingincreased steerability or maneuverability.

Some examples of the disclosure provide for a delivery system havingless time consuming positioning of an implant at a target site in theheart.

Some examples of the disclosure provide for a delivery system havingless time consuming attachment and detachment of an implant to a medicaldevice for efficient positioning and repositioning of such implant atthe annulus.

Some examples of the disclosure provide for a delivery system having anincreased accuracy in positioning an implant at the annulus and therebyreducing the risk of complications.

Some examples of the disclosure provide for a delivery system having areduced risk of damaging the cardiac valve implant during a repair orreplacement procedure.

Some examples of the disclosure provide for a delivery system having abetter ability to retrieve and reposition an implant.

It should be emphasized that the term “comprises/comprising” when usedin this specification is taken to specify the presence of statedfeatures, integers, steps or components but does not preclude thepresence or addition of one or more other features, integers, steps,components or groups thereof.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other aspects, features and advantages of which examples ofthe disclosure are capable of will be apparent and elucidated from thefollowing description of examples of the present disclosure, referencebeing made to the accompanying drawings, in which

FIGS. 1a-b are cross-sectional views of an example of a commissurelocator device of a delivery system for delivery of an annuloplastyimplant.

FIG. 2 is a view of an example of a coronary sinus contractor of adelivery system for delivery of an annuloplasty implant.

FIG. 3 is a view of an example of a coronary sinus contractor of adelivery system for delivery of an annuloplasty implant.

FIG. 4 is a view of an example of a coronary sinus contractor of adelivery system for delivery of an annuloplasty implant.

FIG. 5a is a view of an example of a coronary sinus contractor of adelivery system for delivery of an annuloplasty implant in a deliverystate.

FIG. 5b is a view of an example of a coronary sinus contractor of adelivery system for delivery of an annuloplasty implant in an activatedstate.

FIG. 6a is a view of an example of a coronary sinus contractor of adelivery system for delivery of an annuloplasty implant in a deliverystate.

FIG. 6b is a view of an example of a coronary sinus contractor of adelivery system for delivery of an annuloplasty implant in an activatedstate.

FIG. 7a is a view of an example of a commissure locator device and acoronary sinus contractor of a delivery system for delivery of anannuloplasty implant.

FIG. 7b-d are further views of an example of a commissure locatordevice.

FIG. 8 is a view of an example of a delivery and retrieval device of adelivery system for delivery of an annuloplasty implant.

FIGS. 9a-b are views of an example of an annuloplasty implant fordelivery with a the delivery system.

FIG. 10 is a cross-sectional view of an example of a stapling device ofa delivery system for delivery of an annuloplasty implant.

FIG. 11 is a flowchart of a method of using a delivery system fordelivery of an annuloplasty implant.

DESCRIPTION OF THE PREFERRED EXAMPLES

Specific examples of the disclosure will now be described with referenceto the accompanying drawings. This disclosure may, however, be embodiedin many different forms and should not be construed as limited to theexamples set forth herein; rather, these examples are provided so thatthis disclosure will be thorough and complete, and will fully convey thescope of the disclosure to those skilled in the art. The terminologyused in the detailed description of the examples in the accompanyingdrawings is not intended to be limiting of the disclosure. In thedrawings, like numbers refer to like elements.

The following description focuses on an example of the presentdisclosure applicable to a medical delivery system and in particular toa medical delivery system for delivery of an annuloplasty implant.

Illustrated in FIGS. 1-2 is an example of a delivery system 1 fordelivery of an annuloplasty implant. The delivery system 1 comprises acommissure locator device 10 for locating a commissure, and a coronarysinus contractor for temporary insertion into the coronary sinus (CS)and having a displacement unit 301 being temporarily transferable to anactivated state in which the shape of the annulus of the heart valve ismodified to a modified shape (A′) (FIG. 5b ) to be retained by theannuloplasty implant. The commissure locator comprises an extensionmember 13 and a catheter 12, and wherein the extension member 13 isextendable relative the catheter 12 for location of at least onecommissure of a cardiac valve. By using the commissure locator device 10and the coronary sinus contractor 20 the operator can in an easy andquick way find a desired location for implanting the annuloplastyimplant and at the same time downsize the mitral valve so that thedesired shape can be fixated by the implant that is guided into place byaid of the commissure locator device. This provides for in improved andsecure fit of the annuloplasty implant to the mitral valve, and therebyincreased patient safety when restoring the valve function. Thus asynergetic effect is obtained, since the downsizing provided by thecoronary sinus contractor can be optimally utilized due to the exact andstable positioning of the implant provided by the commissure locatordevice (as described further below), and further, due to thestabilization of the valve anatomy provided by the commissure locatordevice, and improved positioning of the implant, the coronary sinuscontractor will allow for a more controlled and user-definable amount ofdownsizing of the anatomy. The system 1, is further illustrated in FIG.7, described further below.

In an example, illustrated in FIG. 8 (and FIG. 7) the delivery system 1also comprises an implant delivery and retrievable device 30. By usingthe implant delivery and retractable device 30 it is possible to alsoarrange the annuloplasty implant at the desired location at the mitralvalve in a quick and easy way and if needed re-deploy the annuloplastyimplant.

In an example, illustrated in FIG. 10, the delivery system furthercomprises a stapling device 40 for final securement of the annuloplastyimplant at the mitral valve. The stapling device 40 allows for easy andquick securement of the annuloplasty implant.

The following will give more examples of the individual components ofthe delivery system 1.

Commissure Locator Device

The commissure locator device comprises a catheter 12 with a proximalend and a distal end. The commissure locator device 10 further comprisesan extension member 13 at least partly arranged inside the catheter 12with an operator end and a measurement end and wherein the measurementend of the extension member 13 is extendable relative from the distalend of the catheter 12 for apposition with at least one commissure of acardiac valve, such as a mitral valve of the patient and wherein ameasure related to the selection of the annuloplasty implant shapeand/or size is based on at least an extended length of the measurementend of the extension member 13 from the distal end of the catheter 12,positioned at the cardiac valve, to the at least one commissure. By useof the commissure locator device 10 providing the measure related to theselection of the shape and/or size of the annuloplasty implant anoperator of the commissure locator device 10 is facilitated to in aneasy and reliable way decide on the shape and/or size of theannuloplasty implant.

Catheter 12 used herein this disclosure is of well known types andwherein the catheter 12 is capable of comprising at least an extensionmember 13 according to this disclosure. Additionally the catheter 12 iscapable of being rotated and/or otherwise steered into position at thecardiac valve from a desired position in or outside the body by theoperator.

In an example the extension member 13 is a rod or alternatively a poleand/or another long thin member with a cylindrical, circular, squared orrectangular base, capable of being arranged in the catheter 12. In anexample the extension member 13 is a rod extended perpendicular from thecatheter 12 outwards towards the commissure. In another example theextension member 13 is of a semi-circular shape such as a leaf shapedand where the semi-circular shape is directed towards the at least onecommissure and has a spring action for apposition to at least onecommissure. In another example of the extension member 13 the extensionmember 13 has an oval cone shape for apposition to at least onecommissure. The oval cone shape is in example formed of at least oneextending sheet. In another example the oval cone shape is formed fromseveral braided, extending or interwoven shape members.

In another example the extension member 13 is rotationally arranged inthe catheter 12 for apposition with the at least one commissure. Inanother example the extension member 13 is slidably arranged in thecatheter 12. These arrangements allow for easy use and movement of theextension member 13 and catheter 12. Alternatively, the arrangementallows for easy use and movement independently of each other.

The extension member 13 is made of a suitable material compatible withand for use in a catheter 12 and in a heart, such as of titanium,nitinol, polymer, carbon fiber, textiles, all in solid forms or inbraided or sandwich structure forms, etc. The extension member 13 has alength that is at least as long as the catheter 12 and a distance fromthe catheter 12 to the at least one commissure. The extension member 13is preferably long enough to be operated at the operator end by theproximal end of the catheter 12 and still extendable at the measurementend at the distal end of the catheter 12, Le. the extension member 13extends out of and from the catheter 12 at both ends of the catheter 12when used by the operator.

In another example of the extension member 13 has a length wherein themeasurement end of the extension member 13 only extends out and from thedistal end of the catheter 12 and the operator end of the extensionmember 13 is arranged at level with the proximal end of the catheter 12,Le. the extension member 13 only extends from the catheter 12 at thedistal end of the catheter 12 when used by the operator. By using themanoeuvrable extension member 13 the operator measures a distance fromthe catheter 12 at the cardiac valve to the at least one commissure andbases the size and/or shape of the annuloplasty implant on the distance.

In one example the measure related to the annuloplasty implant's shapeand/or size is indicated at the operator end of the extension member 13.By having the operator end of the extension member 13 indicating themeasure related to the size and/or shape of the annuloplasty implant,the operator can quickly and with ease visually see which annuloplastyimplant the operator should choose.

Another example of the measurement end of the extension member 13comprises two sections a, b, separable towards each of the mitralvalve's commissures. By using two sections a, b, that are separabletowards two commissures at the mitral valve a distance between the twocommissures is measured immediately and faster than when using theextension member 13 without the two separable sections a, b.

In other example the two separable sections a, b, are upon extensionfrom the catheter 12 aligned in a plane extending along a direction ofthe proximal end of the catheter 12. By having the two separablesections a, b, aligned and extended in the plane parallel to thedirection of the catheter 12 the two sections a, b, will be easier tocontrol due to their shared alignment with the direction of the catheter12. This can be in b where the separable sections a, b, of the extensionmember 13 are separated perpendicular to the catheter 12.

Further, in yet another example the two separable sections a, b,separate with an opposite inclined separation angle. By having the twosections a, b, separate with opposite inclined angle of separation thetwo separable sections a, b, extend the same distance outwards towardsthe commissures and thus are easier to apposition with the twocommissures due to their synchronised extension.

The two separable sections a, b, are in one example an integralcontinuation of the extension member 13. By having the two separablesections a, b, being the integral continuation of the extension member13 the two separable sections a, b, better responds to manoeuvres, suchas rotation and/or extension of the extension member 13 performed by theoperator. Additionally, a requirement for manufacturing of the extensionmember 13 is greatly reduced since the extension member 13 and the twoseparable extensions are made in one piece. In one example the twoseparable sections a, b, and the extension member 13's mechanicalaspects such as increased breaking resistance and/or improved rotationalforce, are greatly improved because the extension member 13 and the twoseparable sections a, b, are sized and/or shaped dependent on eachother.

Alternatively, the two separable sections a, b, are joined to themeasurement end of the extension member 13. By allowing the twoseparable sections a, b, to be joined at the measurement end of theextension member 13 they may be manufactured from a different materialthan the extension member 13 and thus have other material propertieswith respect to bending, rotation and/or biocompatibility.

In another example the extension member 13 comprises two separablesections a, b, which further comprises a c-shaped or claw shaped end.This claw shaped end is large enough to encompass an edge of a valveleaflet when aligned at the at least one commissure so that theextension member 13 is further secured at the at least one commissure.

In one example the commissure locator device 10 further comprises aforce detection unit connected to the extension member 13 for detectionof a manoeuvre force applied to the extension member 13. By using theforce detection unit for detecting the manoeuvre force applied to theextension member 13 it is possible to get a further more reliableindication of when the extension member 13 is at apposition or incontact to or with at least one commissure.

In a further example of the extension member 13, the measurement end ofthe extension member 13 comprises anchoring means for attaching anchorsat at least one commissure for the annuloplasty implant. Alternatively,one anchor is attached at one commissure. By having the extension member13 comprising anchoring means for attaching anchors for the annuloplastyimplant it is possible to detect the location of the at least onecommissure and following the localization attach anchors at thecommissure so that the annuloplasty implant can be anchored. This allowsfor fast deployment of the annuloplasty implant after the at least onecommissure is found and the size and/or shape of the annuloplastyimplant has been chosen. In an example the anchoring means is a claw orsimilar that allows for gripping the anchors.

In one example, the anchors comprise at least one guiding unit 8, asseen in FIG. 1b . By using at least one guiding unit or rings as anchorsthe annuloplasty implant, which preferably has the shape of a helixring, is rotated into place at the cardiac valve by use of the anchors.For example, when using rings as anchors the annuloplasty implant isinserted through and slides in the rings securing the annuloplastyimplant at the commissures. In an example the anchors are arranged inthe atrium and catch and guides an upper part of the helix ring. Inanother example the anchors are arranged in the ventricle and catch andguides a lower part of the helix ring. In yet another example theanchors are arranged in both the atrium and the ventricle, and catchboth parts of the helix ring and part of the annulus. This allows forthe helix ring to be anchored in different ways from different enteringpoints at the commissure and provides for stabilizing the helix ring atsuitable locations.

As discussed above, in one example the anchoring means comprises anchorsthat are used as guides, i.e. guiding means, for the annuloplastyimplant at the at least one commissure. In another example the anchorsare used alternatively and/or in addition, as means for guiding theannuloplasty implant at the at least one commissure before the anchorsmay be attached at the at least one commissure. This allows the user toboth measure the correct size of the annuloplasty implant and guide theannuloplasty implant into place in an easy way without removing thecommissure locator device 10 when placed at the at least one commissureand at the same time avoid attaching the anchors at the at least onecommissure, thus reducing the time for deploying the annuloplastyimplant in the patient. In this example, the means for guiding is may begenerally open or c-shaped which allows the annuloplasty implant to beguided into place in the heart without attaching the means for guidingat the at least one commissure and which allows for removal of the meansfor guiding, after the annuloplasty implant is implanted in the patient,through the opening of the c-shape. Thus the extension member 13 maycomprise guiding means that are generally open or C-shaped for guidingan implant into place. Other shapes that can be used are substantiallyloop-shaped, triangle-shaped, ring-shaped, such as shown in a, or anyother suitable shape that allows for guiding the annuloplasty implantinto place and/or allows for removing the means for guiding when theannuloplasty implant is implanted in the heart. The extension member 13may have guiding means at each the two lateral parts of the extensionmember 13 that are to be placed at the commissures.

In a further example of the extension member 13 the measurement end ofthe extension member 13 is shaped and/or formed as one coherent member.The extension member 13 may thus be formed as a continuous single orone-piece loop, Le. a closed design. By using the extension member 13formed from one piece closed design the member is much more stable inits construction and easier to manoeuvre in the heart. Further, thecontinuous loop provides for particularly efficient stabilization of theanatomy and improving the precision by which the implant can be placedat the valve. Further, the continuous loop minimizes undesiredinterference with the chordae in the heart that would otherwise be therisk when having projections, edges, kinks etc. The extension member 13may comprise a continuous loop having a distal portion being curvedoutwardly in a direction from the distal end of the catheter 12. Suchcurved shape further reduces the risk of damaging any chordae due thesmooth shape. In the example in a, the distal portion bridges the twoguiding means on the extension member 13. This provides for anatraumatic extension member 13 that effectively stabilizes the valve,while at the same time providing guiding means for the implant. Theprinciple of use and mode of use is the same as for the other examplesof extension member 13 described in this application. Hence, themeasurement, expansion, material and so on are the same and operate inthe same way.

In another example the extension member 13 comprises a leaflet limiter9, FIG. 1a . The leaflet limiter is not limited to be used only with thecoherent extension member 13 but the other types of extension member 13disclosed in this application may also have the leaflet limiter. Theleaflet limiter limits abnormal movement, such as prolapse, of theleaflets into the atrium. Such abnormal movement may arise if a chordae,or several chordae, that usually limits the movement of the leaflet iscompletely destroyed and the leaflet may thus freely move in the leftatrium and/or left chamber. The leaflet limiter is made of a materialthat expands with the extension member 13, and it may be made of thesame material as the extension member 13. The leaflet limiter may alsobe such that it can be bent, twisted or otherwise collapsed into thecatheter 12 and then assume a desired shape when released from thecatheter 12. Alternatively, the leaflet limiter is expanded by a springback motion and/or force when exited from the catheter 12 with theextension member 13. The example of the leaflet limiter shown in FIG. 1a, is a crossbar that extends between two anchoring points of theextension member 13 and is projected laterally from an intersectingplane of the anchoring points of the extension member 13. The leafletlimiter may be of one piece or be made up of several pieces and/or havea number of different shapes and/or have various placements. One exampleof a shape that limits but not damage the leaflet(s) when hindering themovement into the atrium would be to have a simple straight projectionoutwards towards the leaflets from the extension member 13 with a bluntend, which can limit the movement but not damage the leaflet(s) whenhindering the movement into the atrium. Preferably, the extension member13 has two leaflet limiters, one on each side of the extension member 13for each leaflet when the extension member 13 is arranged at thecommissures. But, there could also be only one leaflet limiter. Thiscould be the case if it is known that one leaflet is already damaged andmoving freely when starting the procedure of measuring and/or decidingthe size of the annuloplasty implant.

In an example according to the disclosure a method for facilitatingselection of a shape and/or size of an annuloplasty implant isdisclosed. The method comprises providing a commissure locator device 10such as the commissure locator device 10 for facilitating the selectionof a shape and/or size of an annuloplasty implant as described above.The method further comprises positioning, preferably minimallyinvasively, a distal end of the catheter 12 of the commissure locatordevice 10 at a cardiac valve of a patient. The method further comprisesextending a measurement end of an extension member 13 relative from adistal end of the catheter 12, bringing the measurement end inapposition with at least one commissure of the cardiac valve, such as amitral valve of said patient. The method also comprises basing theannuloplasty implant's shape and/or size on at least an extended lengthof the extension member 13 relative from the distal end of the catheter12 to the at least one commissure. By using the commissure locatordevice 10 for facilitating the selection of the shape and/or size of theannuloplasty implant comprising the catheter 12 and the extension member13 it is possible to base the size/and or shape of the annuloplastyimplant on the extension of the extension member 13 relative from thecatheter 12.

In one example, the catheter 12 is positioned in a substantially centreposition at the cardiac valves. Following the extension member 13 isextended from the distal end of the catheter 12 by an operator pushingthe extension member 13 from the proximal end of the catheter 12 throughthe catheter 12 and out at the distal end of the catheter 12. Themeasurement end of the extended extension member 13 is positioned at,appositioned, or in contact with the commissure.

The positioning of the extension member 13 is performed in a number ofway such as by rotating the extension member 13 relative to the catheter12, sliding the extension member 13 inside the catheter 12, bysynchronised movement of the catheter 12 and the extension member 13and/or by synchronised movement of the catheter 12 and the extensionmember 13 where the extension member 13 and the catheter 12 is engagedso that when movement of the catheter 12 is performed the extensionmember 13 is moved in the same way as the catheter 12.

The extended length of the extension member 13 from the substantiallycentre position to the commissure gives the operator a measure on thesize and/or shape of the annuloplasty implant. The extended length is inone example used as basis for the radius of the annuloplasty implant. Inanother example an assumption that the cardiac valve is symmetricaltogether with the extended length of the extension member 13 is used asbasis for the width of the annuloplasty implant.

In another example of the method for facilitating selection of a shapeand/or size of an annuloplasty implant the basing of the annuloplastyimplant's shape and/or size is based on a measured valve width betweentwo commissures of the cardiac valve by the extension of the measurementend of the extension member 13 relative from the catheter 12 to the twocommissures. Basing the selection of the annuloplasty implant on thedistance between the two commissures gives a better fit of theannuloplasty implant than when only using one commissure. In one examplethe width between the two commissures are measured by sweeping theextension member 13 from one commissure to the other commissure.

In another example the width is obtained between the two commissures byarranging of two separable sections a, b, of the extension member 13separable towards the commissures. The use of the extension member 13comprising two separable sections a, b, separable towards thecommissures results in the width between the commissures being measuredmore accurately and faster than any presently known method. Whenobtaining the width between the commissures by use of the extensionmember 13 comprising two separable sections a, b, the operator positionsthe catheter 12 at the cardiac valve and extends the extension member13. The two separable sections a, b, separate outwards towards thecommissures when they passes the distal end of the catheter 12 by theoperator pushing the extension member 13 through the catheter 12 fromthe proximal end of the catheter 12. Depending on the pushed distance ofthe extension member 13 Le. extended distance of the extension member 13and the two separable sections a, b, the width of the commissures isknown. The separation of the two separable sections a, b, is preferablyat a predefined angle and/or settles at the predefined angle whenmeasuring the width between the commissures. The extension of theextension member 13 from the catheter 12 may be performed in severalways such as, out from the proximal end of the catheter 12 and/or outthrough the sidewall of the catheter 12 at the proximal end.

In one example the method further comprises measuring an appliedmanoeuvre force on the extension member 13 while maneuvering theextension member 13 to apposition the measurement end with the at leastone commissure and, indicating when the measurement end is appositionwith the at least one commissure based on the measured applied manoeuvreforce. By measuring the applied manoeuvre force on the extension member13 applied by the operator the indication of when at least onecommissure has been found is performed more reliable than by use oftactile indication through the extension member 13. The measurement ofthe applied manoeuvre force may e.g. be measured by a force detectionunit.

In one example if the force detection unit is used, the force detectionunit bases the indication of the apposition to the at least onecommissure by comparing the measured applied manoeuvre force with apredefined commissure value for triggering the indication of theapposition of the measurement end with the at least one commissure.

In another example of the method for facilitating selection of a shapeand/or size of an annuloplasty implant an indication is based on ameasured force for stretching the extension member 13 between twocommissures. By measuring the force needed to extend and/or stretch theextension member 13 outwards towards the two commissures it is possibleto detect when the two commissures have been found since the twocommissures have a difference in flexibility compared to other tissue inthe atrium.

In yet another example the method comprises anchoring at least oneanchor at at least one commissure by use of the extension member 13comprising anchoring means. By using at least one anchor at at least onecommissure by using the extension member 13 the operator can attachanchors for the annuloplasty device in one go and with the same device,saving time compared to needed to use a second instrument for attachinganchors. In one example the anchoring means comprises anchors, orguiding means, that are used as guides for the annuloplasty implant atthe at least one commissure. In another example the anchors are usedalternatively and/or in addition, as means for guiding the annuloplastyimplant at the at least one commissure before the anchors are attachedat the at least one commissure. This allows the user to both measure thecorrect size of the annuloplasty implant and guide the annuloplastyimplant into place in an easy way without removing the commissurelocator device 10 when placed at the at least one commissure and at thesame time avoid attaching the anchors at the at least one commissure,thus reducing the time for deploying the annuloplasty implant in thepatient. In this example, the means for guiding is preferably c-shapedwhich allows the annuloplasty implant to be guided into place in theheart without attaching the means for guiding at the at least onecommissure and allows for removal of the means for guiding after theannuloplasty implant is implanted in the patient through the opening ofthe c-shape. Other shapes that can be used are loop-shaped, ring-shapedor any other suitable shape that allows for guiding the annuloplastyimplant into place and/or allows for removing the means for guiding whenthe annuloplasty implant is implanted in the heart.

Delivery and Retrieval Device

The medical implant delivery and retrieval device 30 is illustrated inFIGS. 7-9, and comprises a sheath 101, a wire 102 having a distal end103 and being movable in a lumen 104 of the sheath 101 in a longitudinaldirection 105 of the sheath. The distal end 103 comprises a lockingstructure 107 for receiving and interlock with a complementary matingsurface 108 of a medical implant 200, such as shown in FIGS. 9a-b . Thelocking structure 107 comprises a first locking surface 109 aligned in afirst radial direction (R) (indicated by dashed arrow in FIG. 8) to lockrotational movement of the implant 200, when received in the lockingstructure 107, around the longitudinal direction 105, Le. around thelongitudinal axis 105. The locking structure 107 comprises a secondlocking surface 110 aligned to face a second radial direction (R′),different from the first radial direction (R), to lock movement of theimplant 200, when received in the locking structure 107, transverse tothe longitudinal direction 105. The second locking surface 110 therebyprevents movement of an implant 200 in a transverse direction, such asin the second radial direction (R′) while the first locking surface 109hinders the implant from rotating around axis 105. The implant 200 havea complementary mating surface 108 comprising first 209 and second 210locking surfaces that are positioned opposite, i.e. parallel with, first109 and second 110 locking surfaces of the device 100. By having twolocking surfaces 109, 110, in facing different radial directions, theimplant 200 can be effectively held in place by the device 100 withoutdislocating when handling of the implant. For example, torque caneffectively be transmitted from the wire 102 to the implant 200, due tothe first locking surface 109, while the implant 200 can be keptsecurely in the central position relative the longitudinal axis 105, Le.co-axially positioned relative axis 105 due to the second lockingsurface 110 fixating the implant 200 in the transverse directionrelative longitudinal axis 105, such as in the radial direction. Thisprovides for improved maneuverability of the implant 200 since it iskept in a well-defined secure position relative wire 102 withoutundesired movement relative the latter. The second locking surface 110provides for fixating the position in several directions transverse tothe longitudinal axis 105, Le. any transverse direction which has anangle towards the second locking surface 110, Le. not parallel to thesecond locking surface 110. The second locking surface 110 provides forsecure retrieval of the implant 200 if repositioning or any otheradjustments becomes necessary during the procedure, since the positionof the implant in the radial direction can be controlled, e.g. in thedirection (R′) or any other transverse direction with a vector componentin a radial direction to the longitudinal axis 105. By securing theposition in the radial direction, the implant 200 can be easilywithdrawn into sheath 101, for removing the implant or just keeping theimplant in the longitudinally locked position as described furtherbelow. In this example, if the position of the implant 200 is notsecured in a second radial direction, as provided by the second lockingsurface 110, it will be more difficult or impossible to withdraw theimplant 200 into the sheath 101. It should be noted that the firstlocking surface 109, besides from preventing rotational movement of theimplant 200, also stops movement of the implant 200 in a radialdirection, different from the (second) radial direction in which thesecond locking surface 110 stops movement. A radial direction in thisdisclosure should be construed as directions having any angle of 0-360degrees around the longitudinal axis 105. For example, if the firstlocking surface 109 is aligned to face a radial direction (R) of 0degrees, then the second locking surface may be aligned to have a radialdirection (R′) of 90 degrees as exemplified in FIG. 8.

The locking structure 107 may comprise a recess 106 adapted to interlockwith the complementary mating surface 108 to lock longitudinal movementof the implant 200, when received in the locking structure 107, alongthe longitudinal direction 105. Recess 106 mates with a correspondingprotrusion of the complementary mating surface 108 to fixate theposition along the longitudinal axis 105. This further provides forimproving control of the positioning of the implant 200 in the device100 in order to accurately deliver, manipulate, and possibly retrievethe implant 200 during a procedure. The recess 106 allows the implant200 to be drawn into the sheath 101. The locking structure 107 may thusbe arranged to receive the complementary mating surface 108 when thelocking structure extends outside the sheath 101, and to interlock withthe complementary surface 108 and fixate the position of the implant 200relative the locking structure 107 when the locking structure isretracted within the sheath 101. Hence, when in the withdrawn position,the sheath 101 restricts movement of the implant 200 in a radialdirection in which the implant was received into the locking structure107 in the extended position.

The first (R) and second (R′) radial directions may be substantiallyperpendicular. This may provide for a more optimal locking engagementwith the implant 200, as the first and second locking surfaces 109, 110,thereby complements each other in restricting movement in any radialvector component which is not parallel to any of the surfaces. Even ifnon-perpendicular locking surfaces 109, 110, would also cover all anglesof movement, a perpendicular arrangement may make the connection betweenthe locking structure 107 and the complementary mating surface 108 ofthe implant 200 easier. The second radial direction (R′) may beperpendicular to both the first radial direction (R) and thelongitudinal axis 105. The second locking surface 110 may however alsoform an angle relative the longitudinal axis (not shown), e.g. so thatthe surface 110 is part of a tapered distal portion of the lockingstructure 107. If the distal portion is tapered towards the implant 200it may allow for easier guiding of the implant 200 into the distalportion of the locking structure 107, while at the same time providingfor locking transverse movement when interlocked as described above.Alternatively, or in addition, the second radial direction (R′) may haveany angle relative the first radial direction (R).

The locking structure 107 may be open radially outwards to receive thecomplementary mating surface 108 in a radial direction. This providesfor convenient interlocking with the implant 200 since the implant canbe approached from the side and guided radially inwards.

The first and/or said second locking surface 109, 110, may besubstantially flat. Hence, while the locking structure 107 provides forcontrolled fixation of the implant 200 the mating surfaces of thelocking structure 107 and the implant 108 have a minimum of connectingportions that must be aligned, that also makes interlocking easier, andparticularly of subsequent retrieval of the implant 200 is necessary.

Alternatively, or in addition, the first and/or said second lockingsurface 109, 110, may be curved or comprise a curved portion. Thelocking surface may have a sinusoidal shape, however it may also bepossible to have any concave or convex shape, or a combination thereof.The implant 200 will in this example have a corresponding complementarycurved shape. The surface of the curved portion has a normal direction(perpendicular to the tangent of the curve) that points in varyingradial directions.

The first locking surface 109 may be continuous with the second lockingsurface 110. The implant 200 can be easier to capture and retrieve ifthere is a smooth path for the implant to follow when being positionedin the interlocked state. A continuous locking surface may look inseveral directions while allowing an implant to slide into position. Thefirst and second locking surfaces 109, 110, may be overlapping in thelongitudinal direction 105. This provides for a simplified lockingstructure 108 that may be easier to use and manufacture. The first andsecond locking surfaces 109, 110 may thus be provided as a singlesurface.

The first and second locking surfaces 109, 110, may also be displaced adistance (D) in relation to each other in the longitudinal direction105. This may provide for better stability in the longitudinal direction105 since the implant 200 is locked at each locking surface 109, 110,along the longitudinal direction 105. It may thus require a larger forceto accidentally angle the implant relative the longitudinal direction105.

The second locking surface 110 may be a recess in the first lockingsurface 109. The recess will have a surface facing a second radialdirection (R′) different from a first radial direction (R). Accordingly,the recess will be effective in stopping rotational movement and alsomovement transverse to the longitudinal direction 105, when interlockingwith a corresponding mating surface of the implant 200, Le. aprotrusion. Alternatively or in addition the second locking surface 110may also be protrusion in the first locking surface 109.

The wire 102 may comprise a pivotable locking portion having a closedand an open position. The closed position of the pivotable lockingportion locks movement of the implant 200, when received in the lockingstructure 107, in a radial direction. The radial direction may be thefirst radial direction (R). Since the first locking surface 109 facesthe first radial direction (R), it may be desirable to fixate theposition of the implant 200 in the direction of the normal to the firstlocking surface 109. This allows the implant 200 to be fixated in alldirection without having to retract the locking structure 107 inside thesheath 101. Further, the pivotable locking portion 113 may grab theimplant 200 if it's going to be retrieved. This may facilitateengagement of the implant and locking the implant 200 into the correctposition before retracting the implant inside the sheath 101, or to geta stable hold of the implant before it is repositioned at the targetsite. The pivotable locking portion may also be arranged to lock theposition in the second radial direction (R′) or in any other radialdirection. The pivotable locking portion may be mounted to rotate arounda pivoting axis at the wire, and may be engaged with a separate lockingwire (not shown) to be moved between the closed and the open positionwith an angle. In one configuration the locking portion has a lockingstructure with a recess with a first locking surface, and also a secondlocking surface, that engages with a complementary mating surface of theimplant. Hence, instead of having the locking surface at the distal endof the wire, it may be provided at the pivotable locking portion. Thedistal end of the wire that receives the implant may have a recess, suchas a partly cylindrical portion which receives a correspondingcylindrical portion of the implant. This may allow the implant to easilyengage with the wire before locked into position by the pivotablelocking portion. In an alternative arrangement the second lockingsurface may be omitted. The first locking surface of the pivotablelocking portion mates with the implant to fixate the position in thelongitudinal direction, and to stop rotational movement of the implant,while the recess of the wire, such as a partly cylindrical portion,hinders movement of the implant in a direction transverse to thelongitudinal direction, e.g in a direction perpendicular to thelongitudinal direction and the first radial direction (R). This mayallow easy fixation of the implant while maintaining stability.

The medical implant delivery and retrieval device 100 may comprise aretrieval element (now shown) connecting the locking structure 107 andthe implant 200 when the implant is disconnected from the lockingstructure 107. The retrieval element may hence serve as a security wirethat can be engaged to retract the implant towards the locking structure107 if desired. This may allow for easier navigation of the implant 200towards the locking structure 107 and improving the security of theprocedure.

Alternatively or in addition, the locking structure 107 may comprise anelement (not shown) for attracting the implant 200 with a force, such asa magnet. Also, the magnet force may be switchable to an off state thatmay ease detachment of the implant 200 from the locking structure. Theimplant may also be pushed away from the magnet with a pusher (notshown) that is movable within a lumen of the locking structure 107 andexiting and extending beyond a distal end thereof, in order to againdisengage the implant 200 after being captured with the magnet.Insertion of such pusher in the locking structure may disengage thefirst and/or second locking surfaces from the implant 200.

The sheath 101 may be steerable or shaped to allow for an improveddelivery and/or retrieval angle of the implant 200, so that it can bemore easily and accurately positioned. The sheath 101 may have adelivery configuration where it extends along a 3-dimensional path toposition its distal end at a defined angle. Thus, the sheath 101 mayassume a desired curve shape to optimize the positioning of the implantsuch as an annuloplasty ring or helix. The resulting angle from whichthe implant 200 can be delivered may thus be flat and close to parallelwith respect to the valve, which allows for accurate positioning andeasy insertion of the implant 200 when it exits the sheath 101. Theimplant 200 may be shaped from a flexible alloy such as Nitinol, and itis pre-shaped by heat treatment to assume a desired shape when exitingthe sheath or catheter 101. In addition the implant 200 may comprise anatraumatic tip at its distal end, such as a partly spherical portion, toavoid damaging the tissue.

A kit is disclosed according to one embodiment comprising a medicalimplant delivery and retrieval device 100, and an annuloplasty implant200 such as an annuloplasty ring or helix, wherein the annuloplastyimplant 200 comprises the complementary mating surface 108 at an endportion thereof for interlocking with the locking structure 107 themedical implant delivery and retrieval device 100.

An annuloplasty implant 200 is disclosed according to one embodiment,see FIGS. 9a-b , such as an annuloplasty ring or helix comprisingcomplementary mating surface 108 at an end portion thereof forinterlocking with a locking structure 107 of a medical implant deliveryand retrieval device 100 extending along a longitudinal direction 105.The mating surface 108 comprises a first locking surface 209 aligned ina first radial direction (R) to lock rotational movement of the implant200, when received in the locking structure 107, around the longitudinaldirection 105. The mating surface 108 comprises a second locking surface210 aligned to face a second radial direction (R′), different from thefirst radial direction (R), to lock movement of the implant 200, whenreceived in the locking structure 107, transverse to the longitudinaldirection 105. The complementary mating surface 108 may be shaped tomirror any shape such as described above for the locking portion 107 ofthe device 100.

The system for deployment and/or retrieval of an implant, according toan example of the invention is further illustrated in FIG. 7a . Thecatheter 12′ has a proximal end and a distal end and the catheter 12′ isconfigured to be positionable within a heart adjacent to a cardiacvalve. The system further comprises a coupling device 3 arranged at thedistal end of the catheter 12′ which comprises a coupling memberconfigured to engage at least one pre-determined cardiac structure forcoupling and aligning the catheter 12′ in a known direction in theheart. The coupling device 3 may comprise the commissure locator device10 having extension member 13 as described above for locating andpositioning at the commissures for fixation and/or stabilization of thesame. The catheter 12′ may have at least one angled side port 4, betweenthe proximal end and the distal end of the catheter 12′, adapted for theinterventional device such as an implant 200 (not shown), to passthrough from an interior of the catheter 12′ to an exterior of thecatheter 12′, or vice versa, and for steering the implant, to a desiredtarget point A in the heart. The delivery and retrieval device 30,holding the implant 200, may thus pass through the side opening 4. Byusing a catheter 12′ with at least one angled side port 4 and thecatheter 12′ having a coupling device 3 arranged at its distal end it ispossible to align and anchor the catheter 12′, by use of the couplingdevice, relative to any cardiac structure in the heart. This allows forany interventional device, to be deployed and/or retrieved through theangled side port with a high accuracy of reaching and/or hitting apreferred target point A in the heart. Such interventional devices, maybe selected from the group consisting of suturing devices, staplingdevice 40 (as shown in FIG. 10), radiofrequency electrodes, suctioningdevices, grasping or delivery devices such as the device 30 (FIG. 8),annuloplasty implants 200 and/or other tools used for interventionalcardiac procedures. In one example, an additional port 6 is arranged atthe distal end of the catheter 12′ for straight access for theinterventional device, see FIG. 7b . The catheter 12′ in FIG. 7b has twoangled side ports 4, and 4′, for deployment or delivery of tools orimplants. Any number of side ports may be used, depending on theapplication.

Cardiac structures which may be utilized for coupling include the atrialwalls, inter-atrial septum, valve annulus, valve leaflets, valvecommissure's, valve chordae, papillary muscles and ventricle walls.Preferably at least one commissure of the cardiac valve, is utilised. Byusing the commissure or commissures, it is possible to use an easilyreached and recognisable structure in the heart for alignment andsecurement of the steering system since the commissure(s) is protrudingfrom the heart wall, and is shaped like a wedge, between the leafletsthus allowing the steering system to be aligned in a predetermined way.

The at least angled side port is in one example angled towards thecardiac structure in the heart. By angling the side port in a directiontowards the cardiac structure that is of interest A, the interventionaldevice, will be steered and hit this target point A with ease and a highaccuracy since the catheter 12′ and the cardiac structure will move insynchrony with each other when the catheter 12′ and coupling device isaligned and anchored to the heart.

In another example of the system 1, the angled side port is angledtowards the coupling device. By angling the side port in a directiontowards the coupling device the interventional device, will hit thecoupling device with a high accuracy and ease and the coupling devicemay in turn direct the interventional device, further to deploy and/orretrieve the interventional device, not easily reached from the catheter12′ due to an obstruction in a direct path to the target site.Alternatively, it is easier to steer the interventional device, at thecoupling device when the anatomical structure of interest is in contactwith the coupling device. In yet another example, the angled side portis angled such that the target point A is reached based on the shape ofthe interventional device, that is used for the deployment and/orretrieval. By adapting the angle of the angled side port to the shape ofthe interventional device, used for the deployment and/or retrieval itis possible to hit a specific target point A without altering apreferred shape of the interventional device. This allows for devices tobe used “out of the box” together with the steering system by a simpleadaptation of the side port instead of the interventional device.

In one example the catheter 12′ comprises at least two lumens. By havingat least two lumens it is possible to in an easy way guide theinterventional device, in a vicinity of the angled side port when movedinside the catheter 12′ within one of the lumens, allowing for easierdeployment and/or retrieval of the interventional device, from theinterior to the exterior of the catheter 12′, or vice versa.

One example of an even easier way of guiding the interventional device,to the side port, is that the distal end of the catheter 12′ isconnected to one of the at least two lumens and wherein the angled sideport is connected to an end of the other of the at least two lumens. Byhaving the end of one of the at least two lumens connected to the angledside port it is possible to in a very easy way guide the device to theangled side port since the lumen will be bend or otherwise configured toend at the angled side port so that the device will follow the path ofthe lumen to reach the angled side port.

In one example, the interventional device, that is deployed and/orretrieved through the angled side port is an annuloplasty implant 200.By using the side port 4, 4′, it is easy to deploy an annuloplastyimplant in the heart since the direction of the angled side port isknown and the shape of the annuloplasty implant is known and whichcombined makes it possible to hit the target point A of interest fordeploying the annuloplasty implant. In another example, as describedabove, the coupling device is first targeted and then used for directingthe annuloplasty implant 200 through the commissure 11 or commissuresinto place at mitral valves 11′, see FIG. 7c . In the example shown inFIG. 7c the annuloplasty implant 200 is a helix ring with a lower ring200 positioned below the valve in the ventricle, and an upper ring 201positioned in the atrium, trapping the valve tissue therebetween.

In one example the coupling device is extendable from the interior ofthe catheter 12′ to the exterior of the catheter 12 at the distal end ofthe catheter 12′. By having the coupling device extendable, i.e.collapsible and expandable, from the catheter 12′ it is possible toadjust the relation between the coupling device and the catheter 12′ foreven a more versatile steering system. It also achieves an easyconstruction of the steering system were the coupling device may bedeployed after the catheter 12′ and manipulated by an operator firstlyto achieve the anchoring and alignment of the coupling device and thenlooking the catheter 12′ in place, secondly. Such locking mechanisms maybe any kind of protrusions on the coupling device inside the catheter12′ or outside the catheter 12′ for engagement with a correspondingingrowth on the catheter 12′ so that the two are locked when engaged.

In one example, the coupling member of the coupling device comprises anextensible wire 3′ that is deployed radially outward to engage thecardiac structure, see FIG. 7d . By using an extensible wire as thecoupling member an easy but still rigid and secure coupling device isachieved.

In another example, the coupling member comprises at least one radiallyexpansible superior loop and at least one radially expansible inferiorloop, wherein the superior loop contacts a superior surface at thecardiac structure and the inferior loop contacts an inferior surface atthe cardiac structure when the loops are in an expanded position tocapture a portion of the cardiac structure between the loops, such aswith the commissure locator 30. By having the coupling member beingshaped like an “hour-glass” it is possible to have an easy but yeteffective coupling member that conforms to the shape of the cardiacstructure such as the commissures for anchoring and alignment of thecatheter 12′ and coupling device. Other types of coupling members arealso used that are more suitable to other shapes of cardiac structuressuch as stents, cages, snares, screws and so on.

According to another example of the invention a method for deployingand/or retrieving at least one interventional heart device, used inheart procedures wherein the method comprises a step of introducing acatheter 12 into a heart adjacent to a cardiac valve, wherein thecatheter 12′ has a distal end and a proximal end. A further step ofplacing a coupling device arranged at the distal end of the catheter12′, comprising a coupling member configured to engage at least onepre-determined cardiac structure for coupling and aligning the catheter12′ in a known direction in the heart. And even further a step ofretrieving and/or deploying the at least one interventional heartdevice, through the at least one angled side port on the catheter 12′,wherein the angled side port is between the proximal end and the distalend of the catheter 12′. By using the method as described above foraligning and anchoring the catheter 12′ and the coupling device an easy,quick and reliable way of deploying and/or retrieving the interventionaldevice, is achieved.

In one example the retrieving and/or deploying is performed by a secondcatheter 12′ through the at least one angled side port of the catheter12′. By using the second catheter 12′ a straight path is used forhitting the desired target point A.

Various ways of entering the heart is possible with the steering systemand the introducing of the catheter 12′ into the heart may be performedtransseptal, transaortic and/or transapical.

FIG. 7 also illustrates the coronary sinus contractor 20 of the system1, used in conjunction with the commissure locator device 30. Thesynergetic advantages of the aforementioned components of system 1 havebeen described above. The components of the coronary sinus contractor 20is described in more detail below.

In one example a complete procedure for performing an annuloplastyprocedure in accordance with the above disclosure comprises the stepsof, with no limitation in the order in which the steps are carried out:introducing through a femoral vein a septal wall device to a septalwall; puncturing the septal wall with the septal wall device allowingaccess to the left atrium; introducing a coronary sinus contractingdevice for forming the mitral valve annulus; forming the mitral valveannulus with the coronary sinus contracting device; inserting of acommissure locator and expander device, or the steering system describedabove through the septal wall puncture; deploying a helix ring in leftatrium; maneuvering the helix ring into position through a posteriorcommissure placement; fastening the helix ring in a perpendiculardirection to a mitral annulus; and removing of devices, leaving thehelix ring securely in place. By using the above described method ofdeploying an annuloplasty implant, a quick, easy and reliable way isachieved. The method 1000 is further described with reference to FIG.11.

Coronary Sinus Contractor

The coronary sinus (CS) lies adjacent the mitral valve (MV) and followsa curvature around the annulus (A) of the MV.

The coronary sinus contractor 20, FIGS. 2, 36, comprises displacementunit 301 for temporary insertion into a coronary sinus (CS) adjacent thevalve, wherein the displacement unit has a delivery state (FIG. 5a ) fordelivery into said CS, and an activated state to which the displacementunit is temporarily and reversibly transferable from the delivery state.The displacement unit comprises a proximal reversibly expandable portion302, a distal anchoring portion 303 being movable in relation to theproximal expandable portion in a longitudinal direction 304 of thedisplacement unit (so that the distance (L) between the two portions302, 303, is reduced as seen in FIGS. 6a-b ) to the activated state inwhich the shape of the annulus is modified to a modified shape (A′)(FIG. 5b ); and an annuloplasty device 102 for permanent fixation at themitral valve annulus by annuloplasty of the valve when the modifiedshape is obtained (FIG. 5b ). The annuloplasty device 102 comprises afixation structure 103 that is adapted to retain the modified shape. Bymoving the distal anchoring portion 303 in the longitudinal directiontowards the proximal expandable portion 302 the radius of curvature ofthe CS and also the valve annulus can be reduced. The modified shape ofthe annulus is then fixated by the annuloplasty device 102, beforeremoving the displacement unit 101. Previous prior art devices forinsertion into the C8 are for permanent implantation and are not adaptedto be removed or used in conjunction with an annuloplasty device 102.Alternatively, the prior art devices are focused bending of a segmenteddevice only. The combination of reducing the length of the displacementunit 301 and having a proximal expandable portion 302 that efficientlyprovides a counter force against the anchoring portion 303, greatlyimproves the downsizing effect. Absence of a proximal expandable portionwill make the downsizing considerably more difficult. The system 300allows for improved efficiency treating diseased valves due to efficientdownsizing of the valve via the CS and subsequent fixation of theannulus at the valve itself. Both the proximal expandable portion 302and the distal anchoring portion 303 are reversibly expandable fordelivery and retrieval from a sheath 310, see FIG. 6a . In oneembodiment the distal anchoring portion 303 and/or the proximalexpandable portion 302 may pivot towards the longitudinal direction 304in order to be easily retracted into the sheath 310, see FIG. 2. Thedistal anchor is inserted and fixated into the CS and the proximalreversibly expandable portion 302 folds out from the sheath 310 to allowfor performing the downsizing and is then folded back into the sheath310 and is retracted.

The implant 200 is adapted to retain the modified shape of the annulusin the delivery state of the displacement unit after temporaryactivation in the activated state. The implant 200 may be a helix ringthat pinches the tissue of the leaflets, and fixation of the helix ismay also be done by the stapling device 40, to retain the modifiedshape.

The distance (L) between the proximal expandable portion 302 and thedistal anchoring portion 303 in the longitudinal direction 304 decreasesto a reduced distance (L′) when the displacement unit 301 is transferredfrom the delivery state to the activated state, see FIGS. 6a-b . Sincethe distal anchoring portion 303 is fixated in the CS decreasing thedistance between the proximal expandable portion 302 and the distalanchoring portion 303 will result in a reduced radius of curvature ofthe CS which will downsize the valve. Thus, the radius of curvature ofthe displacement unit 301 decreases when the displacement unit istransferred from the delivery state to the activated state.

The proximal expandable portion 302 may be reversibly foldable to anexpanded state for positioning against a tissue wall 305 at the entranceof the CS, as shown in FIG. 4. This provides for a very stable fixationof the position of the proximal expandable portion 302 relative thedistal anchor 303 for improved control of the downsizing of the valve.Since the proximal expandable portion 302 may be shaped and adapted forpositioning against the tissue wall 305 at the entrance of the CS, andnot inside the CS itself it also reduces the risk of damaging the CS.Also, since the proximal expandable portion 302 is positioned outsidethe CS it is not constrained by the size of the CS and can thus bereversibly expanded to a diameter that spreads the force over a largerportion, thus reducing the pressure on the tissue. This also reducesrisk of damages.

The proximal expandable portion 302 may comprise expandable wire lobes306, 307, for positioning against the tissue wall 305 at the entrance ofthe CS, see FIG. 4. The wires lobes are adapted to be fixated againstthe tissue wall outside the CS, and provide for a stable fixation point.The wire lobes 306, 307 may expand on either side of the sheath 310 tospread the force symmetrically for controlled positioning. Anyexpandable structure such as a balloon etc. may be provided as proximalexpandable portion 302 for reversible expansion against the tissue wall305 at the entrance of the CS, i.e. outside the C8 to provide the abovementioned advantages.

The proximal expandable portion 302 may have a larger expanded diameterthan the distal anchoring portion 303 in the activated state of thedisplacement unit 301. This is e.g. illustrated in FIG. 3, and allowsthe proximal expandable portion 302 to be more securely positioned inrelation to the anchor 303 for a more controlled downsizing.

The distal anchoring portion 303 is expandable to anchor against said CSin the activated state of the displacement unit 301. It providessufficient force against the C8 to be fixated relative the proximalexpandable portion 302 when pulling the distal anchoring portion 303towards the proximal expandable portion 302.

The distal anchoring portion 303 may comprise an expandable coiled wire311, see FIG. 3. The coiled wire provides for efficient fixation againstthe CS, since pressure is provided evenly and circumferentially alongthe length of the coil, while at the same times allows to be easilyretracted into the sheath 310 by extending the coil in the longitudinaldirection 304. The coiled wire may be connected to a control wire 308,FIG. 3, which is adapted to stretch the distal anchoring portion to areduced diameter delivery shape, and reduce tension on the coiled wirein the activated state to expand the distal anchoring portion. Hence, italso allows for easy deployment of the distal anchor in the C8 byreducing the tension on the coil so that it can be retracted andexpanded in diameter for fixation against the CS. Further, the coil 311provides for keeping the body lumen open so that blood flow can bemaintained.

The displacement unit 301 may comprise a delivery wire 309, FIGS. 3 and6 a-b, adapted to deliver the distal anchoring portion 303 and to pullthe distal anchoring portion 303 towards the proximal expandable portion302 in the activated state, whereby the distance (L) between the two isreduced to the shorter distance (L′), as illustrated in FIGS. 18a-b , toprovide the downsizing. The control wire 308 for the anchoring portion303 may be pulled simultaneously and with the same displacement so thatthe anchoring portion maintains its length in the longitudinal direction304.

The proximal expandable portion 303 may be reversibly foldable to anexpanded state where the proximal expandable portion 303 has a diametersubstantially larger than the diameter of the CS. This allows for a morestable fixation outside the CS with the advantages mentioned above.

The anchoring portion may comprise a tissue retention portion such as atleast one hook (not shown). The tissue retention portion provides forefficient fixation of the anchoring portion 303 inside the CS, thatallow for efficient downsizing of the valve annulus. Any number ofretention portions can be used, to optimize the efficiency of theprocedure. In addition to hooks, other retention members grasping thetissue can be provided. The retention portions are preferably orientedtowards the myocardial wall of the CS which is more robust for graspingof the retention portions.

The anchoring portion 303 may comprise a tissue apposition portion (notshown) having a tissue atraumatic surface, such as an at least partlycurved or spherical surface. The tissue apposition portion provides forexerting a counter force against the wall of the CS, stabilizing theanchoring portion 303, and allowing for the retention portion to moreefficiently grasp the tissue and anchor against the same. Also, it helpskeeping the CS vein open for sustaining a flow of blood, in addition tothe coil 311 which also keeps the CS vein open. By having a tissueatraumatic surface, the tissue apposition portion enhance the anchoringability while at the same time reducing the risk of tissue damage to thewall of the CS.

The tissue retention portion may be expandable in a directionsubstantially perpendicular to the longitudinal direction 304. It maytherefore efficiently engage the wall of the CS. For example, theretention portion can be formed of a metal alloy having a heat set shapewhere it assumes an outwardly curved shape, for engaging the tissue. Theretention portion may be connected to the delivery wire 309, such thatwhen the delivery wire is pulled back relative the proximal expandableportion 302, the retention portion grasp the tissue, anchors theanchoring portion 303, and draw the tissue against the proximalexpandable portion 302 to achieve the reduced length (L′) and thedownsizing effect. Alternatively, or in addition, the retention portionmay be connected to a separate control wire (not shown) so that theradially outward expansion of the retention portion can be controlledindependently of the position of the delivery wire 309. Thus, theretention portion may first be retracted, e.g. within the coil 311,before pushed in the longitudinal direction 304, where it may assume theheat set radially expanded shape for grasping the tissue as discussed.

The tissue apposition portion may be controlled and deployed in the samemanner as described in the preceding paragraph for the retentionportion, e.g. being connected to delivery wire 309 or a separate controlwire (not shown), such that the tissue apposition portion can beexpandable in a direction substantially perpendicular to thelongitudinal direction 304 for contacting the all of the CS.

The tissue retention portion and said tissue apposition portion may beexpandable in substantially opposite directions. This allows the tissueapposition portion to provide a good counter force relative theretention portion for efficient grasping of the tissue and secureanchoring. Also, while the retention portion is directed to the strongermyocardial wall, the tissue apposition portion 313 is placed against themore sensitive side of the CS.

The displacement unit may comprise, at a radial portion thereof, atleast one radiopaque marker for rotational alignment of the displacementunit in the CS. E.g. the tissue apposition portion may have a radiopaquemarker for assisting in orienting away from the myocardial wall.Alternatively, or in addition the retention portion may comprise aradiopaque marker 109.

A method for treating a defective mitral valve (V) having an annulus (A)is disclosed comprising; inserting a flexible and removable elongatedisplacement unit 301 in a delivery state into a coronary sinus (CS)adjacent the valve, positioning a proximal expandable portion 302against a tissue wall 305 at the entrance of the CS, positioning adistal anchoring portion 303 inside the CS, activating the displacementunit in an activated state whereby the distal anchoring portion is movedin a longitudinal direction 304 of the displacement unit to reduce thedistance between the distal anchoring portion and the proximalexpandable portion such that the shape of the annulus is modified to amodified shape (A′), fixating an annuloplasty device 102 at the mitralvalve annulus when the modified shape is obtained, whereby theannuloplasty device comprises a fixation structure 103 that is adaptedto retain the modified shape, removing the elongate displacement unitafter temporary activation in the activated state.

Stapling Device

The stapling device 40 for fixating the implant 200 to tissue with aclip 205 is shown in FIG. 10. The stapling device comprises a sheath 401having a distal end 402 for delivery of the clip, and a pusher unit 403,403′, being movable inside the sheath along a longitudinal direction 404of the sheath. The distal end comprises a clip guide 405, 405′, in whichthe clip is movable in the longitudinal direction. The clip guide has aclosed configuration in which the clip guide is adapted to apply arestraining force on the clip so that the clip assumes a delivery shape.The closed configuration of the clip guide 405, 405′. The clip guide405, 405′ also has an open configuration in which the clip 205 assumes arelaxed shape. The pusher unit 403, 403′, is movable from a proximalposition (P) in which the clip guide is in the closed configuration, toa distal position in which the pusher unit 403, 403′, engages the clipguide 405, 405′, and the clip guide is in the open configuration.

By a single step movement, of the pusher 403, 403′, from the proximalposition to the distal position the clip 205 is transferred from thedelivery shape to the relaxed shape. If the clip 205 is inserted intothe tissue in the delivery shape it can thus be conveniently and quicklytransferred to towards the relaxed shape, in which it may clamp thetissue and fixate the position of e.g. an implant such an annuloplastyimplant. The single step movement also provides for a simple andinexpensive device to manufacture, which also can be made as asingle-use disposable device. The clip 205 may be preloaded into thesheath 401. Since the clip 205 has its delivery shape already when thepusher 403, 403′, is in the proximal position there is no additionalaction needed to engage the clip 205 to transfer it into the deliveryshape. This also allows for achieving improved stability in thelongitudinal direction 404 as explained below when the clip 205 is inthe delivery shape, and allowing for further guiding in the longitudinaldirection 404 when the pusher is engaged to the distal position.

Thus, by having a clip guide 405, 405′, in which the clip 205 is movablein the longitudinal direction 404 of the sheath, while being transferredfrom the closed to the open configuration, the position of the clip inthe longitudinal direction 404 can be ensured to thereby attain highstability and accuracy when positioning of the clip 205 in the deliveryshape until the clip is fixated in the relaxed shape. For example, whenthe pusher 403′ moves from the proximal position (P) to the distalposition (P′), the clip 205 moves in the longitudinal 404 direction inthe clip guide 405, 405′. In the proximal position of the pusher, whenthe clip 205 is restrained to assumes its delivery shape, the clip 205can be positioned in the tissue due to the legs 200, 200′ extending welloutside the clip guide 405, 405. In this configuration, the clip guideholds the clip securely, since it functions as a guide in thelongitudinal direction, so that the clip can be inserted into tissuewithout tilting or otherwise dislocate relative the longitudinal axis404. As the pusher 403′ moves to the distal position the clip guides405, 405′, guides the clip 205 in the longitudinal direction,maintaining a stable delivery path, while the clip assumes the relaxedshape. The stable delivery path in the longitudinal direction 404 makesure that there is no uncertainty in the position of the clip relativethe sheath, crucial e.g. when operating in difficult conditions. Therelaxed shape of the clip 205 may be determined by heat treatmentprocedure, and the clip may be formed of a nitinol or another suitablematerial for heatsetting. The clip 205 may not fully assume its relaxedshape when inserted into tissue due to the counter force exerted fromthe tissue on the clip, but the clip will strive to the relaxed shapewhich results in a compressive force between the clip and tissue.

The clip guide 405, 405′, may comprise a clip track 406, 406′, beingarranged to partly enclose a leg 200, 200′, of the clip 205 and applythe restraining force previously mentioned and thereby align the clip inthe longitudinal direction 404 when the clip guide is in the closedconfiguration. Hence, when the clip is in the delivery shape, the cliptrack 406, 406′, of the clip guide may force the leg, or legs 200, 200′,of the clip 205 into a certain position such as in the longitudinaldirection. The clip tracks 406, 406, may thus also be aligned in thisdirection. However, it is conceivable that the clip tracks 406, 406′,may have an angle relative the longitudinal axis 404 in certainapplications in order to be able to deliver the clip in a certain anglerelative the sheath. By having a clip track 406, 406, an improvedalignment of the clip can be provided so that it follows a desired pathwhen being transferred from the delivery shape in which the legs arerestrained, to the relaxed shape. Upon moving the pusher 403′ to thedistal position, and transferring the clip to the relaxed shape, theclip tracks 406, 406′, may continue to steer the legs 200, 200′, of theclip 205 in the desired path, even if the clip tracks 406, 406′, do notfully enclose the legs 200, 200′, of the clip 205. The pusher 403′ maybe shaped to pass through, between or at the side the clip tracks 406,406′, while latter still provide guiding of the clip along the desiredpath.

The clip guide 405, 405′, may comprise two guide parts 407, 408, 407′,408′, being separable in opposite directions B, B′ and in directionsperpendicular to the longitudinal direction 404. The separation of thetwo guide parts 407, 408, 407′, 408′, removes the restraining force onthe clip so that the clip can assume its relaxed shape. This providesfor particularly improved functionality for transferring the clip 205from the delivery shape to the relaxed shape. For example, by having twoguide parts 407, 408, of the clip guide 405 that are separable inopposite directions, the force and also the range of movement requiredto release the restraining force on the clip may me reduced since eachof the guide parts has to travel a smaller distance when being movedfrom the closed to the open configuration. The symmetric action alsoreduce the risk of undesired displacement in a particular directiontransverse to the longitudinal axis 404 when the restraining force onthe clip is released.

The pusher unit 403′ may in its distal position G′ separate the twoguide parts 407, 408, 407′, 408′ in the mentioned opposite directions B,B′, whereby the clip guide 405, 405′, assume its open configuration.This allows for simultaneously moving the clip 205 along thelongitudinal axis 404 with the pusher, i.e. further into the tissue atthe target site, and moving the clip guide from the closed to the openconfiguration so that the clip can assume the relaxed shape to clamp thetissue, and/or securely attach an implant to the tissue. Attaching aclip 205 and fixating tissue and implant in such single step movementprovides for a quicker and easier procedure. The force acting on thepusher 403′ both drive the clip forward and transfers the clip from thedelivery shape to the relaxed shape in a continuous motion. In contrastto prior art, there is accordingly no need to first apply a force ontothe clip with a pusher in order to transfer the clip from a relaxedshape to a delivery shape, insert the clip, and then apply a secondforce in a different direction to the device in order to release theclip to the relaxed configuration while the pusher is already acting onthe clip with the first force. The latter example implies a morecomplicated device that also results in that the total force applied onthe stapling device is increased, e.g. both due to the added secondforce, and due to that the second force must be sufficiently large toovercome the first force acting on the clip, since the forces arecounteracting. This leads to an increase in frictional force against theclip, and such counteracting forces that the operator must apply to thedevice makes handling less precise. Sensibility to movements e.g. of thesurrounding anatomy is decreased in such previous devices. This isresolved with the single-step movement with a pusher force that acts toachieve the two functions as described above.

The two guide parts 407, 408, 407′, 408′ may be separable in directionsB, B′ along a tangent line 409 to the sheath 401. This allows formaintaining a compact profile of the sheath 401 even when the clip guide405, 405′, is in the open position, since the movement is contained asclose to the periphery of the sheath 401 as possible.

The two guide parts 407, 408, 407′, 408′ may each comprise a clip track406, 406′, arranged on either side of a leg 200, 200′, of the clip 205to apply the mentioned restraining force and align the clip 205 in thelongitudinal direction 404 when the clip guide 405, 405′, is in theclosed configuration. By retaining the clip on each side of the leg in aclip track the precision in the alignment of the clip is improved, sinceit is possible for the two guide parts to partly enclose the clip oneither side of the leg.

The clip guide 405, 405′, may be resiliently movable from the closedconfiguration to the open configuration. This provides for a smooth andpredictable resistance acting on the movement of the pusher 403′ whenengaging the clip guide. This allows for a controlled action when movingthe clip from the delivery shape to the relaxed shape and a controlledrelease. The stapling device 40 may comprise a resilient unit 410arranged to apply the resilient force on the clip guide 405, 405′. Theresilient unit 410 may be provided at the periphery of the sheath 401and contacting the clip guide 405, 405′, to counteract movement thereofwith a predefined resistance that can be adjusted by varying theresilience or flexibility of the resilient unit 410. The resilient unit110 may be provided radially outside the clip guide 405, 405′, to applya counteracting force radially inwards. The resilient unit 410 may be aring of flexible material such as silicone or other flexible polymer, orwires of a flexible alloy or fabric.

The pusher unit 403 may comprise a distal tongue 403′ arranged to pushthe clip 205 through the clip guide 405, 405′, in the longitudinaldirection 404 and move the clip guide 405, 405′, from the closedconfiguration to the open configuration. Hence, it provides for movingthe clip 205 along the longitudinal axis 404 with the pusher andsimultaneously moving the clip guide from the closed to the openconfiguration so that the clip can fixated in the relaxed shape. Anarrow distal tongue 403′ allows for a compact design of the clip guideeven in the open configuration, and the tongue 403′ will only displacethe clip guide a small distance relative the diameter of the sheath 401to maintain a compact profile.

The distal tongue 403′ may engage an angled surface 412 of the clipguide 405, 405′, relative the longitudinal direction 404 when the pusherunit 403′ is moved from the proximal position to the distal position, sothat the clip guide is moved from the closed configuration to the openconfiguration. The angled surface 412 allows the tongue 403′ to easilyslide into the correct position and move through the clip guide 405,405′, which improves precision of the and device 40. It also providesfor a more gradual transition from the closed to the open configurationas the angled surface 412 slides against the pusher 403′ with gradualdisplacement in the radial direction. The clip 205 can thus be movedfrom the delivery shape to the relaxed shape more gradually as itadvances along the longitudinal axis 404. This may be desired in certainsituations where it is desired to delay the movement of the clip 205 tothe relaxed shape.

The distal tongue 403′ may be arranged for engagement with the clip 205at an engagement surface having a recess to receive a portion of theclip 205. This provides for increasing the radial stability of the clipas the recess prevents movement in the radial direction.

The clip guide 405, 405′, may comprise a first 405 and a second 405′clip guide arranged at radially opposite peripheries of the sheath 401and extending in the longitudinal direction 404. This is illustrated inthe exemplary embodiment of FIG. 10, and allows for improved accuracy inguiding the clip 205 when moving the clip forward by ensuring guiding atboth sides of the clip being positioned radially across the sheath 401.Tilting or other dislocation of the clip is prevented. The first andsecond clip guides 405, 405′, may be being arranged to partly enclose afirst 200 and a second 200′ leg of the clip, respectively, and align theclip in the longitudinal direction 404 when the clip guide is in theclosed configuration. This further improves the positioning of the clipat the peripheries of the sheath 401. Each of the first and second clipguides 405, 405′, may comprise two separable guide parts 407, 408, 407′,408′ as illustrated in FIG. 10.

The pusher unit 403′ may simultaneously engage the first and second clipguides 405, 405′, when moved from the proximal position to the distalposition, whereby the two separable guide parts 407, 408, 407′, 408′ ofeach of the first and second clip guides are separated to assume theopen configuration. This provides for stabilizing both legs 200, 200′,of the clip to simultaneously as the clip is pushed through the clipguide.

Stapling kit according to one embodiment is disclosed, comprising astapling device 401 as described above and a clip 205 having legs 200,200′. The clip 205 has a delivery shape in which the legs aresubstantially parallel, and a relaxed shape wherein the legs cross eachother. The crossed legs allows for increasing the strength of thefixation of an implant such as an annuloplasty ring to tissue, andpreventing dislocation by locking the implant in place.

The clip 205 may be adapted to form a loop around a first and secondring of a helix-shaped implant positioned on either side of heart valvetissue.

A method of releasing a clip from a stapling device 40 is disclosedcomprising providing a pre-loaded clip in the stapling device 40 havinga sheath and a clip guide at a distal end of the sheath; moving a pusherunit inside the sheath from a proximal position to a distal position toengage the clip guide in which the clip is movable in a longitudinaldirection of the sheath. Moving the pusher to the distal positioncomprises moving the clip guide from a closed configuration, in whichthe clip guide is adapted to apply a restraining force on the clip sothat the clip assumes a delivery shape, to an open configuration inwhich the clip assumes a relaxed shape, whereby when the clip is in therelaxed shape the clip is released from the stapling device 40.

A method is disclosed of delivering a clip to a target site from astapling device 40 as described above. The method comprises providing apre-loaded clip in the stapling device 40 having a sheath and a clipguide, at a distal end of the sheath; navigating the sheath to thetarget site such as a heart valve; attaching a part of the clip to thetarget site for fixating tissue and/or fixating an implant, such as anannuloplasty ring to tissue; moving a pusher unit inside the sheath froma proximal position to a distal position to engage the clip guide.Moving the pusher to the distal position comprises moving the clip guidefrom a closed configuration, in which the clip guide is adapted to applya restraining force on the clip so that the clip assumes a deliveryshape for attaching said part of the clip, to an open configuration inwhich the clip strives towards a relaxed shape where legs of the cliphas a crossed configuration. Moving the clip guide comprises attaching aremaining part of the clip to the target site, and whereby when theremaining part of the clip is attached to the target site, the clipstrives to the relaxed shape and applies a compressive force to thetissue and/or implant for fixating the tissue and/or implant, andreleasing the clip from the stapling device 40.

When said remaining part of the clip is attached to the tissue, legs ofthe clip may form a loop around a first and second ring of ahelix-shaped implant positioned on either side of heart valve tissue.

Method

Illustrated in FIG. 4 is an example of a method 1000 of implanting anannuloplasty implant, with a system disclosed above. First, a punctureand/or cannulation of the femoral vein is performed.

Following, is an insertion of a septal wall device such as a MullinsIntroducer Sheath and/or a Brockenbrough Needle performed.

Then, the commissure locator and expander device is moved into place1001 by use of the septal wall device, in order to find the commissuresin the heart and support the heart during the rest of the procedure. Inan example, the delivery sheath will be withdrawn when device is inposition, allowing the nitinol wire to spring back to a preformed shapeand expanding the commissures to a full extension.

The coronary sinus contracting device, i.e. displacement unit 301, isdeployed 1002, such as via the jugular vein. The coronary sinuscontractor 20 device will ensure the approximation of the mitral annulustowards anterior leaflet for the placement of the helix ring. In anexample the sinus contractor device will be used in parallel with thecommissure stabilizing device, and/or the coronary sinus contractor 20is positioned in the CS before the commissure locator is positioned atthe commissures.

The displacement unit is activated (1003) in an activated state wherebythe shape of the annulus is modified to a modified shape (A′).

Then, a stepwise deployment of the annuloplasty ring 1004, such as ahelix ring, via the left atrium is performed. The ring is deployed intoposition through a posterior commissure placement by use of the implantdelivery and retractable device 30.

Following, the operator fastens the ring 1005 perpendicular to themitral annulus by using the stapling device 40 to retain the modifiedshape (A′).

Finally, the devices, including the displacement unit, are removed 1006,leaving the ring securely in place at the mitral valve.

Activating the displacement unit in an activated state may comprisepositioning 1007 a proximal expandable portion 302 against a tissue wall305 at the entrance of the CS, positioning 1008 a distal anchoringportion 303 inside the CS, activating 1009 the displacement unit in anactivated state whereby the distal anchoring portion is moved in alongitudinal direction 304 of the displacement unit to reduce thedistance between the distal anchoring portion and the proximalexpandable portion such that the shape of the annulus is modified tosaid modified shape (A′). This provides for efficient downsizing of theannulus.

Inserting said implant around the annulus of the heart valve maycomprise guiding 1010 said implant into place by guiding meanspositioned at the commissure locator device at a portion to be arrangedat the commissures. This makes the positioning of the implant easier.

The method 1000 may comprise measuring 1011 the distance between thecommissures by said commissure locator device for receive a measure fordetermining a size of the implant to be inserted. Thus the correct sizeof the implant can thus be advantageously determined simultaneouslyduring the procedure.

The present disclosure has been described above with reference tospecific examples. However, other examples than the above described areequally possible within the scope of the disclosure. Different methodsteps than those described above, performing the method by hardware orsoftware, may be provided within the scope of the disclosure. Thedifferent features and steps of the disclosure may be combined in othercombinations than those described. The scope of the disclosure is onlylimited by the appended patent claims.

What is claimed is:
 1. A method of delivering an annuloplasty implantcomprising, inserting a flexible and removable elongate displacementunit in a delivery state in the coronary sinus (CS) adjacent a heartvalve, activating the displacement unit in an activated state wherebythe shape of the annulus of the heart valve is modified to a modifiedshape, introducing a catheter at the heart valve to deliver theannuloplasty implant, inserting the annuloplasty implant around theannulus of the heart valve, fixating the annuloplasty implant at theannulus when the modified shape is obtained, removing the elongatedisplacement unit after temporary activation in said activated state. 2.Method according to claim 1, wherein the annuloplasty implant comprisesa helix ring, wherein the helix ring is placed through a commissure suchthat a lower ring of the helix ring is positioned below the heart valvein the ventricle, and an upper ring of the helix ring is positioned inthe atrium, trapping the heart valve tissue therebetween.
 3. Methodaccording to claim 1, wherein the catheter has a distal end and aproximal end, the method comprising engaging a pre-determined cardiacstructure with a coupling device arranged at the distal end to coupleand align the catheter in a determined direction in the heart, anddeploying the annuloplasty implant through the catheter.
 4. Methodaccording to claim 3, wherein aligning the catheter in a determineddirection in the heart comprises anchoring the catheter relative to thepre-determined cardiac structure.
 5. Method according to claim 3,wherein the coupling device comprises a commissure locator device, themethod comprising locating the position of the commissures of a heartvalve by positioning the commissure locator device at the commissures.6. Method according to claim 3, wherein the port is angled in adirection towards the pre-determined cardiac structure.
 7. Methodaccording to claim 3, wherein the port is angled in a direction towardsthe coupling device.
 8. Method according to claim 3, wherein thecoupling device is extendable relative the distal end of the catheter.9. Method according to claim 3, wherein the coupling device comprises atleast one radially expandable superior loop and at least one radiallyexpandable inferior loop, wherein the superior loop contacts a superiorsurface at the pre-determined cardiac structure and the inferior loopcontacts an inferior surface at the pre-determined cardiac structurewhen the loops are in an expanded position to capture a portion of thepre-determined cardiac structure between the inferior and superiorloops.
 10. Method according to claim 1, comprising delivering aninterventional heart device, other than said annuloplasty implant,through said catheter.
 11. Method according to claim 10, wherein theinterventional heart device or the annuloplasty implant is deployedthrough a port on the catheter.
 12. Method according to claim 11,wherein the port is angled in a direction towards the pre-determinedcardiac structure.
 13. Method according to claim 11, wherein the port isangled in a direction towards the coupling device.
 14. Method accordingto claim 1, wherein activating the displacement unit in an activatedstate comprises state comprises positioning a proximal expandableportion against a tissue wall at the entrance of the CS, positioning adistal anchoring portion inside the CS, activating the displacement unitin an activated state whereby the distal anchoring portion is moved in alongitudinal direction of the displacement unit to reduce the distancebetween the distal anchoring portion and the proximal expandable portionsuch that the shape at the annulus is modified to said modified shape.15. Method according to claim 1, comprising guiding the annuloplastyimplant into place at the annulus by a guide positioned at the catheter.16. Method according to claim 1, comprising providing a pre-loaded clipin a stapling device, and delivering the clip from the stapling deviceto a target site to fix the annuloplasty implant to tissue at the targetsite, whereupon delivering the clip to the target site the clip strivesto the relaxed shape and applies a compressive force to the tissueand/or annuloplasty implant for fixating the tissue and/or annuloplastyimplant.